New CF drug cocktail enters first human safety tests
NCT ID NCT07035990
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This early-stage trial tests the safety of three experimental drugs (SION-451, SION-2222, and SION-109) given together to healthy adults aged 18–55. The study aims to see if the combinations are safe and how the body processes them. It is a first step toward possibly developing a better treatment for cystic fibrosis, but does not yet involve people with the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SION-451, SION-2222, and SION-109 (oral drugs)
- What this could lead to
- If safe, this could lead to a new combination therapy for cystic fibrosis that helps control the disease more effectively.
- What could go wrong
- This is a very early Phase 1 trial in healthy people, not patients. It only checks safety and drug levels, not whether it works for CF. Many early drugs fail in later stages.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
120 people
The number who actually took part.
- Started
-
Jul 2025
- Finished
-
Mar 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy male or female adult participants aged 18 to 55 years, inclusive, at the time of consent. 2. Weight of at least 45 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening. 3. Participant is willing to abstain from alcohol, caffeine, smoking and nicotine-containing products for 72 hours prior to Day -1 through the duration of the study. Participant is willing to abstain from eating cruciferous vegetables, charcoal-grilled meats, and poppy seeds for 48 hours prior to dosing throughout the duration of the study. 4. Participant has read, understood, and voluntarily provided written informed consent 5. Participant has an understanding, ability, and willingness to fully comply with study procedures and restrictions. Exclusion Criteria: 1. Participant has clinically significant, in the opinion of the investigator, current or recurrent illness, such as cardiovascular (including but not limited to known structural cardiac abnormalities, family history of long QT syndrome, or cardiac syncope or recurrent, idiopathic syncope), neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality which may affect safety or clinical laboratory evaluations. 2. Participant has a history of malignancy, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of recurrence for at least 1 year. 3. Participant has clinically significant abnormalities, in the opinion of the investigator, on ECG, physical examination, or vital sign assessment at Screening or Day -1. 4. Participant has any single reading of QTcF \>470 ms (females) or \>450 ms (males) at Screening or Day -1. 5. Chronic or habitual alcohol (\>10 standard drinks per week) or tobacco (\>10 cigarettes per week) use or use of recreational drugs (\>1 use per month). The Investigator may exclude a participant with lower levels of alcohol, tobacco, or recreational drug use based on discretion and the pattern or history of use.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Nucleus Network
Brisbane, Queensland, 4006, Australia
-
Nucleus Network
Melbourne, Victoria, 3004, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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